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HomeHarm Reduction'Strong science' claimed to be behind FDA decision to permit IQOS marketing

'Strong science' claimed to be behind FDA decision to permit IQOS marketing

America’s Food and Drug Administration last week made the landmark decision to allow the marketing of the cigarette alternative IQOS Tobacco Heating System, which is produced by Philip Morris International, with modified exposure claims, writes Peta Lee for MedicalBrief.

The FDA has emphasised that the authorisation requires the company to conduct post-market surveillance and studies to determine whether the MRTP orders continues to be appropriate, including assessing the potential for increased use among youth.

PMI is elated, seeing this as a significant stride in the company’s commitment to a smoke-free world: it has set a goal that by 2025, 40 million cigarette smokers will have switched to smoke-free products.

The IQOS device uses heat control technology via a blade that warms up the tobacco inside a specially designed stick. Instead of burning the tobacco, it merely heats it so there is no smoke or ash, but PMI’s main selling point is that the percentage of harmful chemicals usually ingested with conventional cigarettes is reduced by 95% with IQOS.

PMI says research has shown that switching completely from combusted cigarettes to electronic ‘cigarettes’ such as IQOS significantly reduces the body’s exposure to 15 harmful and potentially harmful chemicals. Toxicological assessment found that compared with cigarette smoke, IQOS aerosols contain considerably lower levels of potential carcinogens and toxic chemicals that can harm the respiratory or reproductive systems

Explainer webinar

Following the FDA’s approval for the marketing of IQOS as ‘modified risk tobacco products’ or MRTPs, an international Q&A media webinar was hosted by PMI on Friday 10 and Monday 13 July. It included Tommaso Di Giovanni, vice president global communications of Philip Morris International, Dr Moira Gilchrist, vice president, strategic and scientific communications of PMI, and André Calantzopoulos, chief executive officer of PMI.

Gilchrist, who has a degree in pharmacy and a PhD in pharmaceutical sciences from the University of Strathclyde in Glasgow, led the team whose job it was “to translate the robust science behind the company’s smoke-free alternatives into information that policy-makers and the public can easily understand”. She told the webinar audience that the FDA approval for the marketing of IQOS was a triumph for harm reduction.

The research

“This product is a result of more than a decade of research and development by more than 400 scientists, engineers and experts. It has been thoroughly tested and undergone chemistry, toxicology and then clinical studies before first being submitted to the FDA in 2016 and then, three-and-a-half years later, for authorisation.”

It also represents an investment of USD$7.2 billion in PMI’s growing portfolio of advanced smoke-free products. Currently, more than 12.5 million adult smokers globally use IQOS, of whom more than 70% have given up cigarettes.

Gilchrist added that research and development had been intensive. “Underpinning the decision is science-based approval: we submitted more than a million pages of science, requiring proper scrutiny.

“This decision was not made in isolation; everything was done in a very transparent and public way. After first submitting our data to the FDA in 2016, and then the initiation of scientific review, and their delving into the data, experts from around the world then offered their comments to the FDA.”

She said four clinical studies were conducted among adult smokers, with options to stay with regular cigarettes for the study’s duration; quit completely for the duration; or switch to IQOS.

“We observed them for five days in a clinic, and then for a longer term three-month study, during which they went home and then returned for us to check levels of chemicals in the blood and the urine. There were significant differences between those who continued to smoke, and those who switched to IQOS.”

Harm reduction

Cigarettes are extremely harmful, Gilchrist pointed out. “IQOS is a far better choice than continuing to smoke cigarettes”, which is why it was vital to communicate to markets the reduced exposure risks of the product compared with normal cigarettes.

Health organisations worldwide had studied the product and reached similar conclusions, she said: “The Netherlands, Germany, the United Kingdom, for instance, have all concluded that IQOS significantly reduces the harmful chemicals of normal cigarettes and exposure risks, and hopefully can recognise that it’s time to move towards making the product available to smokers.”

Tens of thousands of chemical analyses in the PMI laboratories as well as in other specialist labs worldwide had showed beyond doubt the significant reduction in the harmful chemicals that were present in conventional cigarettes. In the light of this, Gilchrist added, it was important that adult smokers have the necessary (marketing) information to help guide their choice away from nicotine consumption.

PMI CEO André Calantzopoulos said for smokers who would not otherwise quit, IQOS was a better choice, and that the FDA’s approval for the marketing “is the first time such a bold decision has been made for this kind of product”.

IQOS is not risk-free. “It contains nicotine and is addictive, but for smokers who would not otherwise quit, making them aware of IQOS allows them to make a better choice for their lives,” he said.

In the face of opposition from anti-smoking lobbyists worldwide, including governments resistant to any form of electronic cigarettes, he added: “If we continue not making IQOS available to other global markets and adult smokers, they will have no choice but to continue smoking cigarettes.”

In countries like South Korea, for instance, and others where it was difficult or impossible under existing regulations to communicate to consumers information about the product, then governments themselves should be given the information that better alternatives to cigarettes were available, he said.

“It should also be made clear that this marketing is targeting adult smokers only and not intended to encourage non-smokers or teenagers to use it.”

FDA position

The FDA has made no bones about the fact that it does not “approve” tobacco products, and that “the exposure modification orders do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing the products are endorsed or approved by the FDA or that the FDA deems the products to be safe for use by consumers”.

“Through the modified risk tobacco product application process, the FDA aims to ensure that information directed at consumers about reduced risk or reduced exposure from using a tobacco product is supported by scientific evidence and understandable,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.

[link url="https://www.medicalbrief.co.za/wp-admin/post.php?post=110607&action=edit"]Full FDA statement[/link]

 

 

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